SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Phase 3

Completed

Brief Summary: This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Recruitment & Eligibility

Inclusion Criteria

Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

Exclusion Criteria

Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
Subjects with a body mass index (BMI) ≥40.
Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.

Arm && Interventions

Group	Intervention	Description
SI-6603	SI-6603	Condoliase: 1.25U, intradiscal injection, one time For patients in the active treatment group, a volume of 1.0 mL was administered into the intervertebral disc in a single dose.
Sham	Sham injection	Sham injection For patients in the control group, a solution was not prepared and the needle was not placed in the intervertebral disc.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 13 weeks	The primary endpoint was the change from baseline to Week 13 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 52 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days	baseline and 52 weeks	One of the key secondary endpoints was the change from baseline to Week 52 in average worst leg pain score during the past 24 hours over the previous 7 days, as assessed by 100 mm Visual Analog Scale (VAS). VAS is a pain assessment tool with 0 mm representing an absence of pain, and 100 mm representing the worst pain patients have ever experienced.
Change From Baseline to Week 13 in Herniation Volume	baseline and 13 weeks	One of the key secondary endpoints was change from baseline to Week 13 in herniation volume. Herniation volumes were assessed with MRI by a central imaging facility.
Change From Baseline to Week 13 in Oswestry Disability Index (ODI) Score	baseline and 13 weeks	One of the key secondary endpioints was change from baseline to Week 13 in Oswestry Disability Index (ODI) score. The ODI questionnaire is designed to provide information as to how the patient's back (or leg) pain affects their ability to manage in everyday life. A higher score on the ODI indicates a more severe disability. The final index score is calculated as a percentage, with 0% indicating no disability and 100% indicating highest disability.

Locations (65): Delta Clinical Research
🇺🇸
Mobile, Alabama, United States
Pain Medicine Associates, Inc.
🇺🇸
Fountain Valley, California, United States
University of California San Diego - Center for Pain Medicine
🇺🇸
La Jolla, California, United States
The Helm Center for Pain Management
🇺🇸
Laguna Woods, California, United States
The Anand Spine Group
🇺🇸
Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸
Los Angeles, California, United States
Samaritan Center for Medical Research
🇺🇸
Los Gatos, California, United States
UC Davis Spine Center
🇺🇸
Sacramento, California, United States
Source Healthcare
🇺🇸
Santa Monica, California, United States
Boulder Neurosurgical Associates
🇺🇸
Boulder, Colorado, United States
Scroll for more (55 remaining)
Delta Clinical Research
🇺🇸Mobile, Alabama, United States